Dronabinol for Postoperative Pain
(dronabinol Trial)
Trial Summary
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used narcotics in the past 6 weeks or cannabis regularly in the past 3 months. Also, you must be able to take the standardized pain medications like Tylenol, gabapentin, and meloxicam.
What data supports the idea that Dronabinol for Postoperative Pain is an effective treatment?
The available research shows that Dronabinol does not effectively reduce postoperative pain. In a study with 40 women who had surgery, those who took Dronabinol did not experience less pain compared to those who took a placebo. There were no significant differences in pain relief or the time before they needed more pain medication. This suggests that Dronabinol is not effective for managing postoperative pain.12345
What safety data exists for Dronabinol in treating pain?
Dronabinol has been evaluated in several clinical trials for its safety profile. A systematic review and meta-analysis found that dronabinol is associated with higher frequencies of dry mouth, dizziness, and headache compared to placebo, but these adverse events are typically mild-to-moderate and transient. In a study on chronic pain patients using opioids, dronabinol was found to provide additional analgesia with dose-related side effects. Another trial in neuropathic pain patients with multiple sclerosis showed that while adverse reactions were initially higher with dronabinol compared to placebo, they decreased with long-term use, and no significant signs of drug abuse or dependency were observed. Overall, dronabinol is considered a safe long-term treatment option, with the most common side effect being dizziness.13678
Is the drug Dronabinol a promising treatment for postoperative pain?
What is the purpose of this trial?
The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).
Research Team
Jason Jennings, MD
Principal Investigator
Colorado Joint Replacement
Eligibility Criteria
This trial is for adults aged 21-75 undergoing knee replacement at Colorado Joint Replacement who can take oral meds and follow the study plan. They must not have used narcotics in the last 6 weeks, cannabis regularly in the past 3 months, or tobacco recently. No history of major mental disorders, seizures, drug/alcohol abuse, or allergies to dronabinol.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dronabinol or a placebo for 4 weeks post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dronabinol
- Placebo
Dronabinol is already approved in United States, Canada for the following indications:
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- Sleep apnea
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado Joint Replacement
Lead Sponsor